- Merck & Co. (Rahway, NJ)
- …technologies for batch and continuous manufacturing -with a Quality First, Safety Aways Mindset. -The Director Manufacturing Operations (m/f/d) leads teams ... Operations, and Support operations. -The teams operate within a framework of regulatory compliance and established high standards of Quality , Good Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …sites, clinical safety and risk management to uphold the highest quality standards and drive innovation in product stewardship.- As a key senior member ... Job DescriptionThe Senior Director of Device Product Stewardship will lead a...company's product portfolio.-3. Collaborate with cross-functional partners, including R&D, Quality , Regulatory , Manufacturing, Technical Product Leaders, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... capture all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E- Work with the business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device ... medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …seasoned leader to strengthen and grow the Learning and Development program across the Regulatory - Safety - Quality (RSQ) function. In this role you will evolve ... and help create possible, together. **Job Description** The Central Quality Services team within R&D Quality is...program effectiveness + Foster and drive a culture of quality and continuous improvement across RSQ and Development **Change… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... via contact reports. + Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety ...all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Hackensack Meridian Health (Edison, NJ)
- …mission to transform healthcare and serve as a leader of positive change. The ** Director of Patient Safety and Quality , Inpatient** , provides leadership, ... outcomes. **Responsibilities** A day in the life of a ** Director of Patient Safety and Quality...and analysis. + Stays abreast of and communicates all regulatory compliance changes and incorporates findings into all resident/patient… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Director for the Risk Management and Patient Safety Department is responsible for overseeing the day to day operations of the department ... in collaboration with the Executive Director . This includes the coordination and investigation of Serious...within the MSHS. Oversight includes proactive and reactive patient safety initiatives; participation in Root Cause Analysis (RCA) and… more
- Actalent (Basking Ridge, NJ)
- …studies, post-marketing surveillance, signal detection, and regulatory submissions. The Director will ensure proactive safety monitoring through the ... Job Title: Director , Clinical SafetyJob Description The Director , Clinical Safety will be responsible for...+ Coordinate and manage resources to develop and deliver high- quality safety evaluation-related documents and deliverables on… more
- Danaher Corporation (New York, NY)
- …role involves significant cross-functional interactions, coordination with quality and regulatory teams, oversight of external safety boards as needed, and ... that address the world's biggest health challenges. The Senior Director of Medical Safety and Compliance will... safety and compliance strategies with other departments ( quality , regulatory , R&D, and others) + Support… more
- MTA (New York, NY)
- Assistant Director - Safety Engineering Job ID: 8822 Business Unit: Metro-North Railroad Location: New York, NY, United States Regular/Temporary: Regular ... Date Posted: Oct 21, 2024 Description POSTING NO. 8822 JOB TITLE: Assistant Director - Safety Engineering DEPT/DIV: President's Office WORK LOCATION: New York,… more
- City of New York (New York, NY)
- …skills - Demonstrated ability to implement effective process controls and quality improvement initiatives. - Knowledgeable about workplace safety , including ... Job Description The Bureau of Food Safety and Community Sanitation (BFSCS) protects the public,...NOT BE LIMITED TO: Under the supervision of the Director of OTPS, Budget & Grants this candidate will… more
- Compass Group, North America (New York, NY)
- …national hospitality standards. This position is responsible for ensuring that all food safety , regulatory , and quality requirements are met, while ... a career where you can flourish. Job Summary The Director of Quality Assurance will lead the...supply chain preventive controls, and all other prerequisite food safety standards, according to regulatory and Kirkland… more